Required Training (CITI)

Mandatory Training (CITI)

Persons involved with human participants or their identifiable data, and/or the oversight of human research conducted or supported by McLaren Health Care must have a sound understanding and working knowledge of the ethical principles, legal and regulatory requirements, and institutional policies / procedures. Such individuals are obligated to stay current with evolving issues related to the conduct of human research and the protection of human subjects.

One of the primary responsibilities of the HRPP is to ensure that IRB members, IRB staff of the HRPP Office, investigators, members of research teams and those charged with the protection of human research subjects receive and maintain the training and education necessary to fulfill their obligations in the research enterprise.

CITI Training Requirements

MHC IRB requires that all staff involved in the research process (IRB members, IRB staff, researchers, and others involved in the review of human research) be certified via the Collaborative Institutional Training Initiative (CITI) program, which provides research ethics education to all members of the research community.

HRPP will have an oversight mechanism to ensure that all individuals are up-to-date with their required training. (You may also print a certificate of completion for your records at the end of the course)

If you have not previously completed the Basic Human Subjects Research Course or Conflict of Interest Course, taking a refresher course will not satisfy the training requirement. If this is your first time taking the course, you must complete it in its entirety.

The Basic Human Subjects Research Course is required for investigators and key personnel who have not previously completed a CITI human research course. There are two educational tracks for the Basic Human Research Course: Biomedical Research or Social and Behavioral Research. To receive maximal benefit, you should choose the track most closely related to the research in which you are involved. Each track contains up to 16 required modules which take approximately 10 to 30 minutes to complete as well as several optional modules. This training is valid for a 3-year period, after which time a refresher CITI course or additional training must be completed.

All investigators and co-investigators must also complete the Conflicts of Interest Basic Course. This training is valid for 4 years.

New users will be asked to register:

From the CITI web site click on "Register Here" and select McLaren Health Care Corporation under Participating Institutions

Complete Registration steps 1-7

Once you are registered, you may begin the training process!

Returning Users

Refresher Human Subjects Research Course

The Conflicts of Interest Refresher Course

Each refresher course takes an average of 2 hours to complete. Most modules contain a quiz. A minimum aggregate score of 80% is required to pass the courses.

Linking CITI Completion from Another Institution

To link your completed modules from another institution to McLaren Health Care:

Log on to your previous CITI account and click on the "Affiliate with another institution" link.

Type "McLaren Health Care Corporation" into the search box then select it from the drop down menu that appears.

When prompted, choose the "Biomedical Research Investigators" or "Social and Behavioral Research Investigators" course; whichever matches the course work that you completed previously.

Scroll to the bottom of the page and select "Submit"

You will then be prompted to complete any modules McLaren Health Care requires that your former institution did not. Course completion will be registered electronically with the MHC Human Research Protections Program.

To view a previously completed course or print a completion certificate; select the “View Previously Completed Coursework" option from your Main Menu.

Required Clinical Research Coordinators (CRC) Training

CRC may also be referred to as a protocol coordinator, research nurse, research associate, or a medical assistant assigned to role of research coordinator. MCRI Research Managers will notify the Education and Quality Improvement (EQuIP) office of newly hired research coordinators. The QI and Education Specialist will notify McLaren Leadership Development office to assign the CRC to the 7 Habits of Highly Effective Coordinators webinar series on McLaren University with a due date of 6 months from date of hire. New research coordinators will use their McLaren Health Care issued password and user ID to access McLaren University.

Verification of Completion - The EQuIP office will monitor and record completion of webinars through automatic electronic report notification from McLaren University. The EQuIP Office will notify the Corporate Director of HRPP of any research coordinator who has not completed the assignment.